Manager, DEA Compliance

Our Manager, DEA Compliance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing all aspects of DEA reporting and compliance for both manufacturing and laboratory licenses at respective Quva Pharma facilities. This person will be responsible for ensuring that Quva Pharma's manufacturing operations are complying with the Drug Enforcement Administration (DEA) and maintain Quva's commitment to high quality and regulatory standards.

Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is an onsite role located in Sugar Land, Texas.

• Manages and coordinate all DEA related activities at multiple DEA registration locations
• Manages Controlled Substance Inventory, including but not limited to:
  • Raw material, material in process and finished product inventory reconciliation per each lot level
  • Organizes inventory cycle count
  • Organizes middle year, year end and biennial inventory count, and prepare report in compliance with authorities’ requirement accordingly
• Is responsible for implementing and gathering data to support YERS inventories
• Coordinates all movement of control substances from manufacturing through analytical testing
• Trains internal individuals on controlled substance Standard Operating Procedures
• Coordinates all controlled substance destruction with appropriate Quality and Logistics departments
• Coordinates and documents DEA audits for sites and issue audit reports to management upon completion
• Remains current on DEA regulations in order to address organization business needs
• Serves as an expert resource to site management in communicating to the authorities and troubleshooting with respect to Controlled Substances
• Manages Controlled Substances transaction reporting to DEA, and state BOP
• Keeps current on all State Controlled Substance Reporting requirements
• Collaborates with site teams for process excellence programs as SME of DEA compliance
• Collaborates with other critical compliance reports to regulatory agencies as needed, such as theft and loss
• Maintains the DEA compliance documentation system and keep continuously improving the controlled substance management process so to ensure systems meet up to date regulation requirements
• Leads and gathers documentations for DEA, state BOPs and customer audit

• Has a sense of urgency, accountability and resourcefulness
• Advances continuous improvement programs and transformation initiatives
• Is a self-starter and independent learner
• Promotes active listening with team members;
  Contributes appropriately to conversations;
  Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects;
  Improves upon existing approaches by seeking opportunities to creatively transform

• Bachelor’s degree in life science or relevant field
• 5 - 7 years’ work experience in a DEA Manufacturing regulated environment with 3+ years in a leadership capacity
• Experience in maintaining DEA compliance systems
• Implementing compliance systems to maintain corporate compliance of all DEA regulations
• Knowledge in the security requirements
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis;
  Quva is not able to sponsor applicants for work visas

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

Quva provides industry-leading health-system pharmacy…